I researched and found tan excellent plastic surgeon. I was wondering what steps to take to ensure that i was healthy and safe. Link. Immediately, my breathing was cured! 350-1640 When i told the rheumatologist on (b)(6), that i had an implant and that i had made an appointment to see my plastic surgeon the very next day she said, you are right to mention this to me. I was extremely healthy at time of the implant surgery and was told these were fda approved and very safe. I have chronic widespread pain and digestive trouble. The section below provides information and links to the original labeling and updated labeling for each approved breast implant. Breast implant surgery should not be performed in women with active infection . Yet, when i seek the care of specialists, few are able to set a solid diagnosis and i also received clashing diagnosis when seeking second opinions. I started to feel better after that surgery. If you purchased the item online, enter your transaction details and payment method as well. SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST IMPLANT W/DIAPHRAGM VALVE. Staph in left breast, thyroid issues, tumors in my uterus, anemic liver enzymes, elevated alt low vitamin d3. But since the surgery i feel like my lymph nodes are constantly swollen and keep struggling to fight off infections and colds. 304 0 obj <> endobj Best Way to Get a Refund From Sunscreen Recalls, The Easiest Way to Claim the Neutrogena Sunscreen Recall, Best Way to Make Claims on Vehicle Recalls by VIN, What To Do Next If You Have Been Affected By The Philips CPAP Recall, Claim a Refund for Blue Buffalo Pet Food Recalls Today, The #1 Method to Claim a Refund for Rachael Ray Dog Food, How to Claim Your Kia Forte Recall Repair in 5 Easy Steps, The Best Way to Claim a Boon High Chair Recall, Claim a Refund for Clean N Natural Hand Sanitizer Recalls, All About GE Dehumidifier 30 Pint Recalls, How To Make A Claim For The Germ-X Hand Sanitizer Recall, How to Make a Hatfield Shotgun Recall Claim, How to Pay Your Houston Water Bills Online Hassle-Free, How to Remove My Case From The Internet Instantly, How to Recover Your Forgotten Workday Password Hassle-Free, Sending Money to an Inmate Has Never Been Easier, Credit Card Dispute Letter Template That'll Get Your Money Back, Mentor Saline Breast Implants (2021-09-30), General Public, Healthcare Professionals, Hospitals, Contact your doctor for medical advice or an appointment, Contact your plastic surgeon for advice or an appointment, Contact the manufacturer for recall claim procedures, Collect all documents outlining procedures associated with your implant recall, Collect all documents listing the costs of recall of your breast implants, In December 2001, Mentor Worldwide LLC submitted pre-market approval for MemoryGel breast implants, In December 2003, the FDA approved MemoryGel implants, September 30th, 2021, Health Canada initiated a Mentor breast implant serial number recall, Mentor saline breast implants with specific serial numbers may have a weakened structural defect causing deflation, Mentor Texas LP. There should be some kind of warning about the dangers of breast implants. This past year has been the worst so far and i just explanted without replacing the implants because i am 100% certain they have been poisoning me and i am disgusted how the medical industry does not take these type of complaints seriously. Link. Left breast had infection both under muscle and within the breast cavity, so implant was removed. Saline-filled breast implants are firm to the touch while gel-filled implants mimic the feel of fat in a patient's body. I started having sensitivity to foods which i never had before and the foods cause pvcs. 350-2275 Her email is [emailprotected] and phone number is (301) 796-6134. I had a red rash on my breast and many symptoms during the initial 8 months before it all made sense. 6. 350-1655 I asked doctors if it could be my implant and they told me, no. Recent study shows patients and surgeons both preferred the MENTOR MemoryGel BOOST Breast Implant as feeling more like a natural breast versus another leading brand. Link. Cultures were done, idc was called in and i had pseudomonas aeruginosa and serratia marcescens. Patient also had developed rashes and pruritis. Distributed in the states of NY, WI, CA, TX, CO, NC, NJ, OH, TN, RI, and IL. In the event of an unexpected qualifying deflation of a MENTOR Saline-filled Breast Implant, Mentor will replace the product, free of charge, for the lifetime of the patient. Please take these off the market. Had frozen shoulder. I hadnt been contacted for several months because the breast tissue itself looked normal. Smooth surfaced implants are not affected by. I got severe spinning vertigo that lasted 6 years. I am disgusted how they use the fda as a scapegoat to dismiss womens health issues with breast implants, and i am also disgusted how the fda blindly approved something with over 25 toxic chemicals to be placed inside a womens body. Immediately following the implantation, i began having two periods per month, which was not something i ever had before. Here are some examples of our many recall request assistance programs. Sometimes cant even have a bra touch it. I am tired all the time despite excellent diet and plenty of exercise. April 2013. FDA Determined. MentorMemoryShape, MemoryGel, and Memory Gel BOOST implants are recommended for augmentation patients who are at least 22 years old, while the saline breast implants are indicated for patients who are 18 years and older. My diet is impeccable, the products i use on my body are as clean as it gets- completely 100% organic, all natural, no preservatives, etc. Extreme hair loss that has created balding (alopecia) on my scalp. After several years of pain and discomfort and being diagnosed with sjogrens syndrome, lupus, arthritis, fibromyalgia, high blood pressure, my plastic surgeon recommends the removal of my implants. There is no specific information regarding any diagnoses or symptoms. Cant handle the sun anymore, can no longer jog/run. On the date listed above, i received breast augmentation with mentor smooth round high profile gel (silicone) implanted ref (b)(4), left lot #6528127, sn # (b)(4) and right lot #5950089, sn # (b)(4). I had upper back and neck weakness. 350-3460. We began to wonder if my illness could have something to do with my implants. When recalls are as vital as a Mentor breast implant serial number recall, you should never ignore them. !C`2D0NzI%jFCBZZ#XJA|r Y^kb?3q4 Link. I was given iv cipro for several days. they have slowly been poisoning my body. I had a foggy brain and extreme fatigue, headaches, insomnia, swollen lymph nodes, puffy eyes, extreme thirst, difficulty concentrating, remembering things and depression, as well as loss of vision (and brown spots on the iris). Ive had gel smooth mentors, 350 cc since 2012 10yrs now and a ton of sypmptons Im reading is ME! More than 10 numbers, contact manufacturer. Possible symptoms of saline breast implant leakages may include: Possible effects of saline breast implant leakages may include: To determine your eligibility for Mentor breast implant recalls, collect all documentation associated with your Mentor breast implant purchase and procedure. Also. hXmo7+br@/M`I8]pqa#yb;7`FERH=:Z+3)5Ii-2ZLyA 350-2425, SMOOTH ROUND HIGH PROFILE SALINE-FILLED MAMMARY PROSTHESIS, 350-3210 I had mentor cohesive gel implants placed. Manufacturer Mentor Texas, LP. During this procedure, the surgeon noted that the right breast was discolored (brown). MemoryShape PostApproval Cohort Study (formerly Contour Profile Gel Core Study) Final Clinical Study Report . Fast--You don't have to spend hours trying to solve the issue, Easy--You don't have to struggle to fill out tedious forms or keep track of all the steps involved in solving your problem, Successful--You can rest assured knowing we'll make the best case for you. I had these mentor silicone implants placed in 2007. Bruise easily. Irvine, Calif., (January 13, 2021) - Mentor Worldwide LLC, the number one global brand in breast aesthetics, and part of . Something needs to happen you have dropped the ball on this. Breast pain near site of implants was dismissed and then appeased by suggestion to take both vitamin e and evening primrose oils (neither helped reduce pain/discomfort). The patient reported to have several undisclosed illnesses within months of getting the implants put in. My newest symptoms are the perioral dermatitis, migraines accompanied with throwing up, swollen tongue, breast soreness 1 side. He did this because the capsule and part of the implant were right on my chest wall, because they were submuscular. Device Failure Study: The summary of findings did not list: sample size, results of the data findings (no clinical data and no visual inspection data), safety findings, recomendations, summary of safety and data, and nor did it list any changes to labeling. This study wasto be conducted in Denmark, Germany, and the UK. Fast forward to five years later, i noticed a lumpy feeling in my right breast one evening. Could barely walk. a few months later things went downhill fast! Smooth mpp gel mammary prosthesis. 7. Link. Now that ive seen the reports on tv and the studies associating silicone implants with a certain type of cancer. D epression, anxiety, brain fog, inability to concentrate, sensitivity to temperature, smells, blurred vision may be just the beginning and I have no idea who might help in this. Link. C reactive protein is measuring 48 or higher. At this point, though, i really just want to feel healthy again and get these toxic bags out!. It was reported that a (b)(6) female patient with history of breast prosthesis implantations was diagnosed with left breast cancer. SQ*ONlG7[Gqt9`)/kKJ`%KP\gmht(1IsNeX|J-J|beLYh7uq&%#y6i/UsBA{GxZB5-8nWW!A`y]4M6AbQb&'g*-i!czb@68CsbD6UHpVq hx/Mebx- s. Cause 2. i am certain my breast implants are causing all of my health issues. She also suffered persistent mild hardening, fatigue, weakness, high homocysteine, moderate c-reactive protein, photosensitivity, hives, itching after sun exposure, brittleness and cracking of nails, easy bruising, shortness of breath, cognitive difficulties, metallic taste in mouth, night sweats, headaches, foul body odor, cognitive dysfunction, nausea, dizziness, hashimotos disease, skin rashes, digestive and gastrointestinal issues, low white blood cells, elevated thyroid and autoimmune antibodies, epstein-barr virus, cytomegalovirus, varicella zoster, and pain (generalized). I have followed every recommendation that has been made in regards to the breast augmentation surgery. I have lost the ability to live my life, play with my son, spend time with friends, make plans, and keep them. Link. 350-1625 2 years post. Link. I immediately felt relief in my joints and muscles as soon as they were removed. Abnormal blood test results since 2012. Link. . DoNotPay is an ever-expanding AI program to assist with a variety of online records or license requests, applications, disputes, claims, recalls, and more. A plastic surgeon implanted me with mentor memory gel silicone breast implants. In doing my research, i trusted the fdas recommendation that these were very safe implants. However, there was nothing changed in my lifestyle or diet to being on any of these changes. It was unknown whether cd30 positive or alk negative. In 2012 the plastic surgeon, dr (b)(6) of (b)(6) told me that this new silicone was perfectly safe, wont travel to other parts of your body if it ruptures, and had at least a 10 year lifespan. All i want is for my original breasts to look normal and not have the muscle flex deformity. Any ideas what this is? Several years after my mentor smooth silicone implants were placed in, i noticed symptoms. The FDA's warning letter to Mentor Worldwide LLC (Mentor) noted several serious deficiencies in the manufacturer's post-approval study for its MemoryShape breast implant, first approved in. No one had any answers for me. From 2014-2015, some studies (e.g. I was in extreme pain, and i began losing my hair. No further information was obtained. Mris of brain to check for memory related causes were inconclusive. Link. I believe as i stated before they have exacerbated my autoimmune challenges. Had mammogram at (b)(6) hospital and became very ill within 3 weeks. MENTOR Breast Tissue Expanders. I did not smoke, do not use drugs, do not consume alcohol and eat very clean. I still have severe ringing in my ear that hasnt left. Do your research ladies, get a $$ loan if you have to, your health is worth it! They also recommended ultrasound at the discretion of the radiologist. 350-3290 April 2013. With the help of DoNotPay, we can ensure that your breast implant recall claims are documented and filed to the fullest extent possible, so you can focus on taking care of your health. MENTOR MemoryGel Breast Implants, MENTOR MemoryShape Breast Implants, and MENTOR Saline-filled Breast Implants are indicated for breast augmentation in women (at least 22 years old for MemoryGel Implants and MemoryShape Implants, and 18 years old for Saline Implants) or for breast reconstruction. It protects physicians to have patients sign informed consent forms, and fittingly they are the ones reporting back a high success rate in informed consent. Mri confirmed that bilateral implants were ruptured. More research needs to be done and patients need to be warned of other medical harm that can happen because of the silicone implants. Approx 7 years ago, i had a breast augmentation done, re-done actually. 350-2225. Link. Lymphedema, autoimmune disease, anemia, permanent muscle and nerve damage, silicone and heavy metal poisoning, loss of appetite, vomiting pain, blood and fluid build up around implants, pain in joints, dizziness, brain fog, confusion, swollen breasts, arms and fingers as well as face, weight loss, faint very easily, stomach pains, swollen lymph nodes and glands, depression, anxiety. They admitted me and performed exploratory surgery, found I had a ruptured right fallopian tube, which they removed. MENTOR MemoryGel Breast Implants and MENTOR MemoryGel Xtra Breast Implants are round devices with shells constructed from medical grade silicone elastomer. Upon further inspection of the inner shell, the surgeon noticed black specs floating in the fluid. Ive been sick ever since. The swelling comes and goes. Wrong! After doing research on my own and some common sense. Link. The site is secure. Dry eyes, blurred vision, double vision, and eye pressure. Since explanting, i already am noticing symptoms subsiding such as my brain fog, temperature regulation and ability to focus clearly. Patient decision checklist, which must be reviewed with the prospective patient by the health care provider to help ensure the patient understands the risks, benefits and other information about the breast implant device. It was reported that memorygel siltex round ultra high 455c (p/n: 3545455; l/n: 7374907-027) had a piece of fiber on it and it did not appear sterile. k-9(J((5*k?aT/SZ D z:Trx%(o8L?h{C5t*Q 350-3310 MENTOR Warranty The recommendations in this guidance supplement the recommendations in the FDA's Saline, Silicone Gel, and Alternative Breast Implants guidance, issued September 29, 2020 superseding the prior version dated November 17, 2006. The rheumatologist took blood tests and results showed i had an autoimmune disease known as scleroderma. Keep this notice visibly posted for awareness until all product subject to this recall has been returned to Sedgwick. I am ASAP to get my life back! Over the past 3-4 years, the intensity of issues has become severe. I had memory gel under the muscle about 10 years ago. An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, Risks and Complications of Breast Implants, Medical Device Reports for Systemic Symptoms in Women with Breast Implants, Medical Device Reports of Breast Implant-Associated Anaplastic Large Cell Lymphoma, Questions and Answers about Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), Things to Consider Before Getting Breast Implants, Breast Implant Postmarket Safety Information, FDA Strengthens Safety Requirements and Updates Study Results for Breast Implants, Breast Implants - Certain Labeling Recommendations to Improve Patient Communication, Saline, Silicone Gel, and Alternative Breast Implants guidance, Allergan voluntarily recalled Natrelle BIOCELL textured breast implants and tissue expanders. Consumers are regularly alerted to product recalls thanks in part to the Consumer Product Safety Act. I thank the rheumatologist for validating the fact that the implant could be the cause. Believe my silicone breast implant was ruptured after a mammogram. We have helped over 300,000 people with their problems. Wound is not healing properly. 350-2375 350-2325. Patient had implants explanted on (b)(6) 2016. Hair was falling out, constantly getting sick with sinus issues cold, cough, infections, strep, sore throat, brain fog, tired, low libido. Mentor Worldwide, LLC. 350-3230 Many test to follow. i plan to find out what all i need to take to detox and try to get all this silicone out of my system! It was reported that a patient underwent breast surgery using memorygel breast implant, siltex round high profile 325cc. The left was adhered to my ribs!!!!! Health product - Medical device - General and plastic surgery. Link. On (b)(6) 2016 she underwent revision operation due to breast implant leak. I have elevated bilirubin levels from toxic overload and have been diagnosed with gilberts syndrome. However, by the first sunday following my surgery ((b)(6)), i was able to take a few steps unaided in my home. She became very ill and had been sick during a business trip, with a fever, swollen left breast and lymph node infection. I began suffering with a poor immune system, memory loss, brain fog, fatigue, insomnia, neuropathy, high blood pressure, migraines, eye sight and hearing and had to have tubes put into my ears and could not get out of bed most days. So, i began my research for answers. Now i rarely leave my house never without assistance. Teague urinary incontinence, dry skin, sjogrens autoimmune, hair loss, burning around the breast tissue, two air forms of thyroid cancer, chronic fatigue. I have also been very consistent with all of my medical visits and live a very healthy lifestyle however i continue to become more ill no matter how clean eating, exercising, and taking supplements and medication recommended by physicians. Alerted to product recalls thanks in part to the breast augmentation surgery silicone elastomer disease known scleroderma! Underwent revision operation due to breast implant, siltex round high PROFILE 325cc regards to the breast augmentation surgery undisclosed. In and i had these mentor silicone implants plastic surgeon implanted me with memory... Since 2012 10yrs now and a ton of sypmptons Im reading is me plan find. Spinning vertigo that mentor memory gel implants recall 6 years all the time despite excellent diet and plenty of exercise pain, and UK! W/Diaphragm VALVE is me healthy at time of the implant were right on breast... 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